Oncology Investors to Hear “Cancer Device Company of the Year” Immunicom Present at MedInvest Conference

On March 26, 2021 Immunicom, Inc., a global biotechnology company pioneering novel "subtractive" immunotherapies, reported CEO Amir Jafri will speak at MedInvest’s 2021 Oncology Investors Conference on March 29 at 12:30 PM. Immunicom was recently named MedInvest’s "Cancer Device Company of the Year – 2021", and Jafri will discuss the unique platform-based vision driving the many such accolades Immunicom’s FDA Breakthrough Device has garnered, and the distinct advantages the platform has over drug-based therapies (Press release, Immunicom, MAR 26, 2021, View Source [SID1234577234]).

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Jafri’s presentation, titled "A New Era in Cancer Care," will speak to the current industry shortcomings and Immunicom’s solution strategy.

"The consequence of the current drug-centric standard of care is the toxicity patients suffer from round after round of drug combinations, which cancers often build resistance to," Jafri said. "So instead of adding substances into the body, our therapy is subtractive – we remove immune inhibitors. These investors eagerly attend these conferences because they know how much room there is for improvement and they’re all looking for what’s next."

Jafri’s confidence in a strategy that is a literal inversion of convention is evident – after founding the company in 2013, he immediately targeted the most difficult advanced cancers to treat, and his three clinical trials underway recruited metastatic patients who had failed multiple rounds of standard therapies. One of those trials resulted in a CE Mark to reduce the immune system inhibitors, sTNFRs, addressing an unmet medical need in triple negative breast cancer patients with advanced refractory metastatic disease, showing improvement in the quality of life, and potential for extension of life, and disease stabilization in these end-of-life patients.

"There are reasons why MedInvest named us ‘Cancer Device Company of the Year 2021’ and is featuring this presentation," Jafri said. "They want to introduce investors to tomorrow’s therapies so tomorrow is better than today."

The conference has the potential, indeed, to enable next generation treatments. Sponsored by the National Foundation for Cancer, it is attended by over 200 of the largest and most serious oncology investors, spanning venture, public funds, foundations, family offices, angels, and government grant making entities. MedInvest presenters represent the industry’s most elite and promising from startups, early pre-clinical through clinical, and public and private companies worldwide.

Jafri’s presentation will follow a keynote address by 2018 Nobel Laureate Dr. Jim Allison, whose work led to development of the first immune checkpoint inhibitor drug Ipilimumab, which was approved for late-stage melanoma by the U.S. Food and Drug Administration in 2011.

Jafri’s presentation will be available on Immunicom’s website on April 2nd. See View Source

Subtractive Therapy – ImmunopheresisTM and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy", in contrast to drugs that are "additive", subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Immunicom believes that the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA). Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

The LW-02 Immunopheresis column is currently being evaluated in several global oncology trials for multiple cancers, including TNBC, non-small cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma. It is being investigated both as a monotherapy and in combination with low-dose metronomic chemotherapy and the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD; and

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.

Study Shows Guardant360 Liquid Biopsy Predicts Response to Pembrolizumab-Based Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer

On March 26, 2021 Guardant Health reported that For patients with metastatic non-small cell lung cancer (mNSCLC), not harboring an actionable mutation, immunotherapy is often recommended for first-line treatment (Press release, Guardant Health, MAR 26, 2021, View Source [SID1234577233]). A new study in JCO Precision Oncology shows the Guardant360 liquid biopsy test provides an early indication of treatment response to pembrolizumab-based immunotherapy by detecting molecular response or changes in circulating tumor DNA (ctDNA) levels early on.10 The study was led by researchers at the Perelman School of Medicine at the University of Pennsylvania.

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The single-center, prospective, observational study evaluated molecular response in patients with mNSCLC (n=51) receiving pembrolizumab-based therapy, as monotherapy or with chemotherapy, as first- or second-line treatment. Changes in ctDNA were evaluated from baseline to nine weeks post-therapy initiation, and correlated with clinical and radiographic response.

In the study, the Guardant360 test showed that molecular responders achieved improved durable clinic benefit (log mean 49.4% vs. 3.5%) and significantly longer progression-free survival (median 14.1 vs. 4.4 months) and overall survival (median 22.1 vs. 12.0 months) compared to non-molecular responders. Molecular response was also associated with radiologic response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) .

"Unfortunately, only a subset of patients with metastatic non-small cell lung cancer will respond to pembrolizumab-based therapy, and their failure to achieve clinical benefit becomes evident after their disease has progressed," said Helmy Eltoukhy, Guardant Health CEO. "This study adds to the growing body of evidence showing that our Guardant360 test can effectively measure molecular response, giving clinicians an earlier indication whether to continue or stop treatment, explore other therapeutic regimens, or enroll the patient in a clinical trial."

The Guardant360 test is used to guide treatment in metastatic non-small cell lung cancer as the number of treatment-relevant genomic alterations continues to grow. Using next-generation sequencing, Guardant360 analyzes 83 genes using cell-free tumor DNA from blood samples. The Guardant360 test is broadly covered by Medicare for use across the vast majority of advanced solid tumors, including patients with metastatic non-small cell lung cancer. Last year, the FDA approved the Guardant360 CDx for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with any solid malignant neoplasm (cancerous tumor).

"These are exciting results that further support the value of liquid biopsies as a noninvasive tool to measure early treatment responses by evaluating molecular response or changes in circulating tumor DNA," said Charu Aggarwal, MD, MPH, Leslye M. Heisler Associate Professor for Lung Cancer Excellence at Penn’s Perelman School of Medicine and Abramson Cancer Center "We look forward to additional studies to help make this approach a reality in the clinical setting to personalize immunotherapy based treatment decisions for patients with metastatic non-small cell lung cancer."

The publication, titled "Serial Monitoring of Circulating Tumor DNA by Next-Generation Gene Sequencing as a Biomarker of Response and Survival in Patients With Advanced NSCLC Receiving Pembrolizumab-Based Therapy," can be found here: doi.org/10.1200/PO.20.00321.

British T-cell cancer biotech Achilles Therapeutics guns for $176M IPO

On March 26, 2021 Achilles Therapeutics reported that $176 million initial public offering for its next-gen immuno-oncology work (Press release, Achilles Therapeutics, MAR 26, 2021, View Source [SID1234577229]).

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The biotech originally came out of Syncona and Cancer Research Technology, which founded Achilles back in 2016 to build on research into cancer and cell therapies done by scientists including Charles Swanton at the Francis Crick Institute, UCL and the Royal Free Hospital.

The collective efforts of those scientists gave Achilles a platform for developing T-cell therapies targeting clonal antigens. These antigens are cell surface proteins unique to each patient’s tumor.

It has already trod a strong financial path, and, back in 2019, Achilles raised an impressive £100 million ($120 million) series B round, which at the time set it up to run human proof-of-concept studies of its personalized T-cell therapies in two types of solid tumors.

Two years down the line, and it now has its leading drug, ATL001, in the clinic: one test is in non-small cell lung cancer, followed up with a green light to run a trial in melanoma patients.

Now, it is asking for $176 million in a Nasdaq IPO to help push further into the clinic and bring more of its pipeline into the fold.

Interim data for ATL001 are expected in the second half of next year, while the company is also plotting to file INDs for its earlier-stage programs in head and neck cancer as well as kidney cancer later this year and in late 2023, respectively, according to its Securities and Exchange Commission filing.

Achilles plans to list under the symbol "ACHL."

Cosmo Full-Year Report 2020: Cosmo returns to operating profit

On March 26, 2021 Cosmo Pharmaceuticals N.V. (SIX: COPN) reported its Full-Year results for the year ended 31 December 2020 (Press release, Cosmo Pharmaceuticals, MAR 26, 2021, View Source [SID1234577220]).

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In 2020, Cosmo received European approval for Methylene Blue MMX, received FDA approval for BYFAVO, continued to execute its equity for product strategy and has returned to operating profit. The Company is very well positioned with €212.9 million in cash and significant equity stakes in other companies.

Financial Highlights Full-Year 2020

Revenue €60.9 million compared to € 62.5 million in 2019.
Net expenses €54.0 million compared to €74.8 million in 2019 following restructuring of business.
Operating profit of €6.9 million compared to an operating loss of €12.3 million in 2019.
Loss after tax of €7.9 million, including share of our associate Cassiopea loss of €4.9 million, compared with a loss after tax of €24.5 million in 2019.
Cashflow inflow from operating activities of €10.1 million compared to a cash outflow from operating activities of €17.6 million in 2019.
Cash & liquid investments €212.9 million compared to €268.2 million 2019, of which €45 million of the movement related to our investment in and loan to Acacia.
Market value of Cosmo’s stake in Cassiopea, equity investments, treasury shares, loans and cash & liquid investments at 31 December 2020 €624.6 million.
Equity €400.1m vs €393.7m at 31 December 2019.
Key Events 2020 – Products and Business

BYFAVO sub-licensed to Acacia Pharma Group (EURONEXT: ACPH) in an equity for product deal and subsequently approved by the FDA. Cosmo now owns 19.66% of Acacia and has advanced a €25 million loan to the company.
Very positive results of the first investigator initiated prospective clinical study of GI Genius announced, ADR (Adenoma Detection Rate) and APC (Adenoma Per Colonoscopy) were significantly higher in the GI Genius group compared to the control group.
GI Genius approved in Australia, Israel and the United Arab Emirates.
Methylene Blue MMX approved in Europe and European rights (plus Switzerland, the U.K., EEA countries, Russia and Mexico) subsequently licensed to Alfasigma S.p.A. in February 2021; protocol and related statistical analysis plan for the confirmatory phase III trial filed with the U.S. FDA for final comment and Chinese rights licensed to China Medical System Holdings Ltd.
Cosmo’s associate Cassiopea S.p.A. received FDA approval for Winlevi (clascoterone cream 1%) for the treatment of acne.
Italian Agenzia del Farmaco (AIFA) granted Marketing Authorisation for Stadmycin (Rifamycin SV MMX), licensed to E.G. S.p.A. (part of the STADA Group), for the treatment of Travellers’ Diarrhoea.
Japan’s Pharmaceuticals and Medical Devices Agency approved Eleview.
Licence agreement with Dr. Falk Pharma Gmbh (‘Dr. Falk’) amended to include Rifamycin SV MMX in the new 600mg formulation.
Successful outcome of phase II proof of concept (POC) clinical trial of Rifamycin SV MMX 600mg in Irritable Bowel Syndrome with Diarrhoea (IBS-D) announced in January 2021.
Key figures

Alessandro Della Chà, Chief Executive Officer, said: "2020 has been a year full of positive events for Cosmo. Methylene Blue MMX was approved in Europe, BYFAVO was approved by the FDA, Cassiopea, our associate, received FDA approval for Winlevi. We continued to execute our equity for product strategy, returned to operating profit and delivered a positive cash flow from operating activities. We have a very strong balance sheet, we are replenishing our development pipeline and we are confident that GI Genius will eventually be approved by the FDA. We therefore look to the future with optimism".

2021 Financial Outlook

Cosmo provided 2021 full year guidance, assuming approval of GI Genius by the FDA, of:

Full year revenues in the range of €60 – €64 million
Total expenses in the range of €57 – €59 million (of which ESOP €5.9 million and Depreciation & Amortisation €6.2 million)
Operating profit in the range of €3 – €5 million
The Full-Year Report 2020 with further information was published today on 26 March 2020, 07:00 am CET, and is available for download at:

View Source

Full-Year 2020 results conference call at 02:00 pm CET on 26 March 2021

Alessandro Della Chà, CEO and Niall Donnelly, CFO will present the 2020 results and discuss the outlook for 2021. The conference call will be held in English.

Ionis to present at upcoming investor conferences

On March 26, 2021 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), the leader in RNA-targeted therapeutics, reported that management will participate in virtual fireside chats at the following investor conferences (Press release, Ionis Pharmaceuticals, MAR 26, 2021, View Source [SID1234577219]):

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3rd Annual Stifel CNS Day on Thursday, April 1, 2021
20th Annual Needham Healthcare Conference on Monday, April 12, 2021
The above listed dates are subject to change. Details on presentation times or changes to presentation dates can be found on the Company’s website. Please check www.ionispharma.com for the latest information.

A live webcast of the presentations will be available on the Investors & Media section of the Ionis website. The replays will be available within 48 hours and will be archived for a limited time.